(HealthDay News) — Brentuximab vedotin plus chemotherapy improves 3-year event-free survival (EFS), compared with chemotherapy alone, in children with high-risk Hodgkin lymphoma, according to a study published in The New England Journal of Medicine.
Sharon M. Castellino, MD, from Emory University School of Medicine in Atlanta, and colleagues conducted an open-label, phase 3 trial involving 587 patients, aged 2 to 21 years, with previously untreated Hodgkin lymphoma of stage IIB with bulk tumor or stage IIIB, IVA, or IVB.
The patients were randomly assigned to receive brentuximab vedotin with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide or the standard pediatric regimen of doxorubicin, bleomycin, vincristine, etoposide, prednisone, and cyclophosphamide for 5 cycles.
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The 3-year EFS was 92.1% in the brentuximab vedotin group and 82.5% in the standard care group (hazard ratio, 0.41; 95% CI, 0.25 to 0.67; P <.001).
There was no significant difference between the groups in the percentage of patients who received involved-site radiation therapy (53.4% in the brentuximab vedotin group and 56.8% in the standard care group).
The 3-year overall survival was similar between the groups, at 99.3% in the brentuximab vedotin group and 98.5% in the standard care group.
There was no increase in toxicity with brentuximab vedotin, according to the researchers.
“The substitution of brentuximab vedotin for bleomycin with chemotherapy in children with Hodgkin’s lymphoma improved disease control at three years but did not improve overall survival and appeared not to reduce the reliance on radiation therapy,” the authors of an accompanying editorial wrote.
Brentuximab vedotin was supplied by Seagen.
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